MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. CARBOCLEAR PEDICLE SCREW SYSTEM

Catalog Number	PNNS7545
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A functional test was performed on the disassembled screw (after re-assembling it).Test included pedicle screw insertion into a bone model (rigid polyurethane foam) using carboclear screwdriver (following proper tapping).Screw was successfully inserted and locked.In addition, screw polyaxiality was examined and found in order.(testing of the second screw, which was damaged during its extraction, was not feasible).Examination of the production records of the involved items indicated they were manufactured according to specification.According to the complaint description, it is possible that the pedicle screws were not tightly connected to the screwdriver prior to their insertion (as instructed in the system surgical technique).
Event or Problem Description
During a surgery in (b)(6), two pedicle screws disassembled while being inserted to l1 vertebra.Screws were removed and another screw was used.(date of event is estimated according to the information provided in the complaint report).

• Brand Name: CARBOCLEAR PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 8284556
• Report Number: 9615128-2019-00001
• Device Sequence Number: 2462599
• Product Code: NKB
• UDI-Device Identifier: 17290110200685
• UDI-Public: (01)17290110200685(17)230701(10)75576A
• Combination Product (Y/N): N
• PMA/510(K) Number: K173487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: PNNS7545
• Device Lot Number: 75576A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1